UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059509 |
|---|---|
| Receipt number | R000068003 |
| Scientific Title | Verification of the effectiveness of acupuncture therapy for working family caregivers whose labor productivity is declining due to caregiver fatigue: A Multicenter Randomized Trial |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/19 12:30:18 |
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Basic information
Public title
Verification of the effectiveness of acupuncture therapy for working family caregivers whose labor productivity is declining due to caregiver fatigue
Acronym
Verification of the effectiveness of acupuncture therapy for working family caregivers whose labor productivity is declining due to caregiver fatigue
Scientific Title
Verification of the effectiveness of acupuncture therapy for working family caregivers whose labor productivity is declining due to caregiver fatigue: A Multicenter Randomized Trial
Scientific Title:Acronym
Verification of the effectiveness of acupuncture therapy for working family caregivers whose labor productivity is declining due to caregiver fatigue: A Multicenter Randomized Trial
Region
| Japan |
Condition
Condition
caregiver fatigue
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To generate scientific evidence regarding the effectiveness of acupuncture therapy in addressing economic losses caused by decreased labor productivity related to presenteeism due to caregiver fatigue among business caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Economic losses associated with decreased labor productivity related to presenteeism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention will consist of acupuncture therapy sessions lasting at least 20 minutes each, administered by research collaborators. The intervention period will be one month, with a frequency of at least once per week (limited to one session per day), up to a maximum of eight sessions.
Interventions/Control_2
Untreated control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who are business caregivers and have been providing family care for more than one month.
Individuals who perceive a decline in their work performance from the start of family caregiving until the time of consent.
Key exclusion criteria
Individuals who have participated in or plan to participate in other studies or clinical trials within one month before or after the time of consent.
Individuals deemed ineligible to participate in this study by the principal investigator or research team.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
s.miyazaki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
Homepage URL
s.miyazaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
Tel
03-5843-3111
rec@thu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068003
